Randomized study evaluating the efficacy and safety of switching from an an abacavir/lamivudine-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen

Giuliano Rizzardini, Andrea Gori, Celia Miralles, Julián Olalla, Jean Michel Molina, François Raffi, Princy Kumar, Andrea Antinori, Moti Ramgopal, Hans Jürgen Stellbrink, Moupali Das, Hoa Chu, Renee Ram, Will Garner, Yongwu Shao, Susan K. Chuck, David Piontkowsky, Richard H. Haubrich

Research output: Contribution to journalArticle

Abstract

Objective:To evaluate the efficacy and safety of switching from an abacavir/lamivudine (ABC/3TC)-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen in virologically suppressed, HIV-1-infected adults.Design:Randomized, open-label, noninferiority study.Methods:Participants with HIV-1 RNA levels less than 50 copies/ml receiving ABC/3TC plus a third agent for at least 6 months were randomized 2 : 1 to switch immediately to E/C/F/TAF (immediate-switch group) for 48 weeks or to continue receiving ABC/3TC plus a third agent for 24 weeks followed by E/C/F/TAF for 24 weeks (delayed-switch group). The primary endpoint was HIV-1 RNA less than 50 copies/ml at Week 24 by Food and Drug Administration Snapshot algorithm (-12% noninferiority margin).Results:Baseline characteristics of 274 participants (183 in immediate-switch group and 91 in delayed-switch group) were similar. Virologic response was maintained at Week 24 by 93.4 and 97.8% of participants in the immediate-switch and delayed-switch groups, respectively, with a treatment difference of-4.4% (95% confidence interval:-9.4 to 1.9%), confirming noninferiority. Adverse events of any grade were similar between groups through Week 24 (66% E/C/F/TAF, 64% ABC/3TC); adverse event-related drug discontinuations occurred in 4% of participants switching to E/C/F/TAF (no discontinuations because of renal events) and no participants continuing ABC/3TC. Renal biomarkers of urine albumin:creatinine and beta-2-microglobulin:creatinine ratios significantly improved on E/C/F/TAF. Self-reported treatment satisfaction was significantly higher with E/C/F/TAF.Conclusion:Switching to E/C/F/TAF was noninferior to continuing ABC/3TC plus a third agent for maintenance of HIV RNA suppression at Week 24. This study supports E/C/F/TAF as an efficacious and well tolerated option for participants switching from ABC/3TC-based regimens.

Original languageEnglish
Pages (from-to)1583-1593
Number of pages11
JournalAIDS
Volume33
Issue number10
DOIs
Publication statusPublished - Aug 1 2019

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Keywords

  • abacavir/lamivudine
  • antiretroviral agents
  • drug switching
  • elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
  • HIV

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

Cite this

Rizzardini, G., Gori, A., Miralles, C., Olalla, J., Molina, J. M., Raffi, F., Kumar, P., Antinori, A., Ramgopal, M., Stellbrink, H. J., Das, M., Chu, H., Ram, R., Garner, W., Shao, Y., Chuck, S. K., Piontkowsky, D., & Haubrich, R. H. (2019). Randomized study evaluating the efficacy and safety of switching from an an abacavir/lamivudine-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen. AIDS, 33(10), 1583-1593. https://doi.org/10.1097/QAD.0000000000002244